1. Jane Lenehan, Scientific Animal Protection Manager (acting)
Clinical Trials and Testing of Veterinary Medicinal Products in Ireland
Jane Lenehan, Scientific Animal Protection Manager (acting)
HPRA Veterinary Medicines Information Day
13 June 2018, Hilton Hotel Dublin Airport

2. Today’s talk Background Application process HPRA evaluation Fees
Conclusion
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3. 1. Background

4. Legislation: Directive 2001/82/EU and SI No 786 of 2007 as amended
Scope
Legislation: Directive 2001/82/EU and SI No 786 of 2007 as amended
Clinical trial: a study which aims to examine under normal field conditions the safety/efficacy of a veterinary medicinal product (VMP) for the purpose of obtaining a marketing authorisation or a change thereof.
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5. Purpose of a clinical trial
To demonstrate/substantiate effect of a VMP after administration at recommended dosage
To specify:
indications & contraindications according to species/age/breed/sex
directions for use
adverse reactions
safety and tolerance under normal conditions of use
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6. HPRA 2016 survey on clinical trials in Ireland
Feedback:
Expertise in Ireland
Proximity to R&D facilities
Cost & speed of applications
Confusion about legislation
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7. 2. Application process

8. Clinical trial application
HPRA licence required prior to commencing any trial in Ireland
HPRA must consult with the Department of Agriculture, Food and the Marine (DAFM) before granting a licence
A copy of application should be sent to DAFM (at time of HPRA application)
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9. Includes permission to import test product
Timeline
R&V
Evaluation
Queries
Complete evaluation
Licensing Committee
Licence issued 40
working
days
Includes permission to import test product
DAFM input
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10. 3. Clinical trial evaluation

11. For veterinary field trial use only
Key requirements
Detailed trial protocol
Trials under veterinary care
Informed owner consent
Good Clinical Practice (GCP) conditions
Control animals
Positive control
Placebo
Untreated control
For veterinary field trial use only
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12. Key areas of evaluation
Trial locations
Quantities of test/control medicines to be imported (where no marketing authorisation in place)
Withdrawal periods in food- producing species
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13. 4. Fees

14. Current Application Fees
€630
New trial – medicine containing a novel substance
€315
New trial – medicine containing established ingredient
€60
Variation to a current licence
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15. 5. Conclusion

16. Main evaluation by HPRA with input from DAFM 40 working day timeline
Summary
Main evaluation by HPRA with input from DAFM
40 working day timeline
Fees €315/ €630
Requirements include GCP, control animals, owner consent, veterinary care, etc.
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17. vetinfo@hpra.ie www.hpra.ie/homepage/veterinary/regulatory-information
For more information
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